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Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate (TURP)

Primary Purpose

Benign Prostate Hyperplasia

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

TURP

About this trial

This is an interventional treatment trial for Benign Prostate Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients with BPH that require TURP

Exclusion Criteria:

Previous prostate surgery
Prostate Cancer
Coagulopathy
The use of NSAIDs, Anticoagulants, Antiplatelet drugs
CRF/ESRD

Sites / Locations

Faghihi Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Finastide low dose

Finastide high dose

Control

Arm Description

2 weeks of daily 5mg finastride before operation

4 weeks of daily 5mg finastride before operation

Control

Outcomes

Primary Outcome Measures

Perioperative Hb Drop

Secondary Outcome Measures

Full Information

NCT ID

NCT01627522

First Posted

June 21, 2012

Last Updated

April 19, 2016

Sponsor

Shiraz University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01627522

Brief Title

Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate

Acronym

TURP

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Preoperative use of finastride will decrease the amount of perioperative blood loss during and after TURP The effect of finastride on decreasing the amount of perioperative blood loss during and after TURP is dose dependent Finastride will decrease microvascular density in prostate tissue and this effect is dose dependent

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostate Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Finastide low dose

Arm Type

Active Comparator

Arm Description

2 weeks of daily 5mg finastride before operation

Arm Title

Finastide high dose

Arm Type

Active Comparator

Arm Description

4 weeks of daily 5mg finastride before operation

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control

Intervention Type

Procedure

Intervention Name(s)

TURP

Intervention Description

Transurthral resection of prostate

Primary Outcome Measure Information:

Title

Perioperative Hb Drop

Time Frame

24 hours after surgery

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with BPH that require TURP Exclusion Criteria: Previous prostate surgery Prostate Cancer Coagulopathy The use of NSAIDs, Anticoagulants, Antiplatelet drugs CRF/ESRD

Facility Information:

Facility Name

Faghihi Hospital

City

Shiraz

State/Province

Fars

ZIP/Postal Code

71344

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26945662

Citation

Aminsharifi A, Salehi A, Noorafshan A, Aminsharifi A, Alnajar K. Effect of Preoperative Finasteride on the Volume or Length Density of Prostate Vessels, Intraoperative, Postoperative Blood Loss during and after Monopolar Transurethral Resection of Prostate: A Dose Escalation Randomized Clinical Trial Using Stereolog Methods. Urol J. 2016 Mar 5;13(1):2562-8.

Results Reference

derived

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Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate

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